Haematococcus Pluvialis Astaxanthin for Brain Aging

ConditionBrain Aging
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50+
SponsorCapital Medical University

About this trial

We recruit community-dwelling older adults aged 50 and above for a 6-month intervention. Participants are divided into three groups:

Placebo Group, Low-Dose Group ( 6 mg/d Haematococcus pluvialis Astaxanthin), High-Dose Group (12 mg/d Haematococcus pluvialis Astaxanthin).

Peripheral blood samples and Other tests are collected at baseline, 3 months, and 6 months to measure mitochondrial function and oxidative stress levels.

Assessments include: 1.Cognitive \& Neurophysiological Assessment: Using the MoCA (Montreal Cognitive Assessmentscale) and ERP (specifically P300) monitoring. 2.Brain Imaging: MRI (Magnetic resonance imaging) is used to analyze changes in brain function. 3.Metabolomics: A series of laboratory techniques are used to analyze routine metabolic indices, plasma astaxanthin, mitochondrial function, oxidative stress markers, and cognition-related neurobiomarkers.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Low-Dose AST

    Dietary supplement

    Low-Dose AST Group:6 mg/d Astaxanthin (Haematococcus pluvialis)

  • High-Dose AST

    Dietary supplement

    High-Dose Group: 12 mg/d Astaxanthin (Haematococcus pluvialis)

  • Placebo

    Other intervention

    Placebo

Treatment groups

120 Participants
are divided into 3 treatment groups
Group A: Placebo GroupPlacebo comparator 1 intervention
Group B: Low-Dose AST GroupExperimental treatment 1 intervention
Group C: High-Dose AST GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Montreal Cognitive Assessment, MoCA

The cognitive domains assessed included attention and concentration, executive function, memory, language, visual structural skills, abstract thinking, as well as calculation and orientation. The total score of the scale was 30 points.A total score of 26 or above is considered normal (as there is no current Chinese reliability and validity analysis, so the original foreign language threshold values can be temporarily referred to); a score of 19 to 25 indicates that there is a possibility of mild cognitive impairment (MCI); if the score is 19 to 22 and there is also some difficulty in daily life/activities, it usually means that the person has progressed from MCI to dementia; those with a score below 19 can clearly be diagnosed as having dementia.

Time frame
From enrollment to the end of treatment at 6 months
2

Neurophysiology changes

The event-related potential (ERP) P300 was used to track the changes of the brain's neural electrophysiology during the cognitive process.Patients with cognitive decline and Alzheimer's disease show an extended P300 latency period.

Time frame
From enrollment to the end of treatment at 6 months

Secondary outcomes

1

MRI(Magnetic resonance imaging)

The Siemens Trio 3T MRI system was used to acquire imaging data, including T1-weighted structural and resting-state functional scans as well as T2w-FLAIR images.The common local brain structural changes associated with cognitive decline are the atrophy of the hippocampus and the entorhinal cortex.

Time frame
From enrollment to the end of treatment at 6 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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